All MACRO personnel and investigator clients have completed U. Pittsburgh research ethics training. Many have also completed NIH research ethics training. MACRO has had no research ethics problems for this time period, nor any since its founding.
For this time period MACRO has had no unanticipated events requiring IRB action or remediation, FDA “for cause” audits, FDA warning letters, nor any other significant regulation violation. MACRO efficiently handles IRB submissions and all other regulatory requirements. Many researchers and coordinators have contacted MACRO for advice on complex regulatory issues such as subject screening, delayed informed consent, and electronic consenting.
Ms. Vera Iouchmanov principally handles regulatory compliance for MACRO. A major project over this reporting time period was successfully creating a system that centralized research billing compliance. This system tracks and confirms that research services are billed properly to research accounts and not to patients or their insurance, and vice versa.
Study monitors have been highly satisfied with MACRO’s work. Select comments are provided below.